medical MODERATE Updated 2017-12-06

Medtronic Inc. recalls Everflex Self-Expanding Peripheral Stent with Entrust Delive

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Recalled Product

Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.

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Hazard / Issue

Stent length on the label may not match the length of the stent itself.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall